TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435

NCT01046058 | Completed Phase 1 DMC

• 2 other identifiers: CR016783TMC435-TiDP16-C113
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the study is to investigate the effect of moderate and severe hepatic impairment on the pharmacokinetics of TMC435. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. In addition, the short-term safety and tolerability of TMC435 in participants with hepatic impairment will be determined. The results of this study will guide dose recommendations for TMC435 in patients with impaired liver function.

Conditions

Hepatitis C Virus

Keywords

TMC435-TiDP16-C113; TMC435-C113; TMC435; HCV; Protease Inhibitor; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic profile of TMC435 in patients with moderate and severe hepatic impairment

  Measured at 16 predefined time points over a period of 9 days. Extensive analysis is planned on Day7 (after last intake of TMC435), with 12 PK sampling moments over 48 hours.

Secondary Outcomes (1)

• Short-term safety and tolerability of TMC435 in volunteers with moderate or severe hepatic impairment

  AEs monitored each visit; vital signs, urinalysis and ECG parameters on Day 7 and on both follow-up visits; Safety blood sample at 6 predefined timepoints (over 5 days) and on both follow-up visits.

Study Arms (2)

Panel A: TMC435 150 mg

EXPERIMENTAL

Participants enrolled in Panel A had moderate hepatic failure and received TMC435 150 mg once daily for 7 days.

Drug: TMC435

Panel B: TMC435 150 mg

EXPERIMENTAL

Participants enrolled in Panel B had severe hepatic impairment and received TMC435 150 mg once daily for 7 days after the safety of TMC435 150 mg once daily for 7 days was evaluated in participants enrolled in Panel A.

Drug: TMC435

Interventions

TMC435 DRUG

150 mg (two 75-mg capsules) orally (by mouth) once daily for 7 days

Panel A: TMC435 150 mg; Panel B: TMC435 150 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with hepatic impairment: Moderate or severe hepatic impairment, clinically diagnosed as Child Pugh B or C
• Stable liver cirrhosis and hepatic impairment for at least 3 months prior to the start of the study. Participants with normal hepatic function: Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram

You may not qualify if:

• Participants with hepatic impairment: Fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment within 3 months prior or within the screening period
• Cirrhosis due to chronic hepatitis B or C infection. Participants with normal hepatic function: History or presence of hepatic disease

Sponsors & Collaborators

• Tibotec Pharmaceuticals, Ireland: lead

Study Sites (3)

Unknown Facility

Anaheim, California, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Related Links

• A Phase I, open-label, sequential trial to investigate the pharmacokinetics, safety, and tolerability of TMC435 in subjects with moderately or severely impaired hepatic function

MeSH Terms

Conditions

Hepatitis C

Interventions

Simeprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Tibotec Pharmaceuticals Clinical Trial

  Tibotec Pharmaceutical Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 11, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

US (3)